The field of this invention relates generally to medical devices and methods for treating hemorrhoid disease, and specifically for reducing the displaced anal cushions associated with hemorrhoid disease.
The condition where the blood vessels covered by rectal glandular mucosa and/or by the modified anal squamous epithelium become dilated and protrude as a mass into the anal canal, has been generally referred to as hemorrhoids or piles. Hemorrhoids are thought to be present in at least half of the world""s population by the age of 50, and are said to be one of the oldest ills known to man. In fact, it has been recently recognized that hemorrhoids are actually normal features of the human anatomy. Hemorrhoids are now considered to be mucosa-covered arteriovenous pads or cushions that normally bulge into the lumen of the anal canal just above the pecten band. As an individual ages, the connective tissue system supporting and anchoring these vascular plexuses of the anal cushions deteriorates and the hemorrhoids gradually descend within the mucosal wall and down the lumen of the anal canal. When the descending hemorrhoids with poorly supportive and anchoring connective tissues pass the pecten band and beyond the Hilton""s line, as often occurring after defecation in older adults, the arteriovenous plexuses may be caught by the constricting lower edge of the internal sphincter. If this happens, the veins in the plexuses become distended because the venous blood cannot escape into the systemic circulation. The vascular anal cushions become increasingly congested, edematous and hypertrophic, and eventually can no longer return to their normal position readily after defecation. This is the basic pathogenesis of hemorrhoidal disease.
In general, there are two types of hemorrhoids: internal and external. Internal hemorrhoids originate from the superior (internal) hemorrhoidal plexus immediately above the pectinate line. By contrast, external hemorrhoids are varicosities of the inferior (external) hemorrhoidal plexus, which lie below the pectinate line. However, because of the communication between the internal and external hemorrhoidal plexuses, most patients have both internal and external hemorrhoids. Traditionally, hemorrhoids projecting into the anal canal are called first-degree; those that prolapse with defecation but reduce spontaneously are called second-degree; those that require manual reduction are called third-degree; and those that cannot be reduced are called fourth-degree.
Hemorrhoids become xe2x80x9chemorrhoidal diseasexe2x80x9d when at least one, and usually three, anal cushions descend into the anal canal from the normal resting position above the anal canal and do not retract back into the normal position. The resulting compression of the venous channels by the sphincter muscles surrounding the anal canal prevents the venous blood from returning to the systemic circulation and causes persistent dilation of the hemorrhoidal veins, so that symptoms begin manifesting. Common symptoms of hemorrhoidal disease include, for instance, local foreign body irritation sensation, pain, and bleeding. Surface erosion, edema and chronic inflammation due to the secondary bacterial infection of the protruding hemorrhoids are also common causes of symptoms, which can render the modified cutaneous portion of the anal canal extremely sensitive to any foreign body irritants, even the stool in the lower rectum.
Various remedies for hemorrhoidal disease have been tried for the past 5,000 years, and to date there are a number of devices for use in treating this condition. Many devices are designed to push the hemorrhoids protruding from the external anal orifice back into the anal canal. For instance, see U.S. Pat. No. 5,924,423 to Majlessi, U.S. Pat. No. 4,583,542 to Boyd, and U.S. Pat. No. 5,178,627 to Hudock. Most of the devices and methods are ineffective or provide temporary relief only, and do not involve retraction of the anal cushions to their normal anatomical position above the anal canal. Other methods involve invasive or surgical therapy, but this is only considered when various types of medical management have failed since surgery may not produce the expected relief and may yield undesirable complications.